Senior Manager Regulatory Affairs, Global Reg Strategy US & Canada
Core
Develop and implement US and Canada regulatory strategic and tactical planning (RSTP) for assigned on-market and in-development products to enable commercialization.
Role type
Senior Manager, Regulatory Affairs (Global Reg Strategy)
Builds
Regulatory strategies and submissions for pharmaceutical products
Domain
Pharmaceuticals / Life Sciences
Required skills
Regulatory strategy development, FDA liaison, regulatory submissions, cross-functional negotiation, government regulation interpretation, project management
Preferred skills
Advanced degree, global regulatory experience, complex matrix environment experience
Technologies
None stated
Responsibilities
Develop and execute regulatory strategies for assigned products; Serve as Health Authority liaison and coordinate FDA meetings and briefing packages; Prepare and review regulatory submissions for US and Canada; Advise internal customers on Regulatory/FDA issues; Recommend and implement changes to projects based on regulatory expertise; Present regulatory information to cross-functional areas
Seniority
Senior Manager, hands-on leadership